by Barbara Maley | May 20, 2021 | Data Management | comments
COVID has drastically changed everything in life — including the way we work and the way that we interact with healthcare professionals. Clinical research is one industry that has been affected the most. Just like physicians, face-to-face interaction is limited or even eliminated in some cases. Electronic patient-reported outcome (ePRO) is no longer an option – it’s the standard as a response to these changes.
In addition to responding to the pandemic, clinical trials were already transitioning to an electronic means of collecting patient data. Electronic data collection provides more accurate results, saves time when analyzing those results, and saves time and money – especially when it comes to clinical trial data management.
In this article, we will discuss:
Our goal with this guide is to equip your team with the deep perspective that helps you conduct and manage the data within your clinical trial.
Electronic patient-reported outcomes (ePRO) in a clinical trial allow participants to answer questions and report their health through smartphones, tablets, or laptops. The clinical trial design is focused on patient experience and many clinical trials today include patient-reported outcomes. Combining patient reporting and technology can have marked increases in patient satisfaction and data accuracy.
ePRO can provide patient data and measure their outcomes in a variety of ways, including:
Health-Related Quality of Life: With ePRO, you can assess individuals both with and without health conditions. Most often used for patients with chronic illnesses, the data collected helps researchers, clinicians, and others to compare groups with and without a condition and estimate population norms. Because the measurement is not disease or condition-specific, you can use this data to calculate quality-adjusted life years or compare the information to current population norms.
Satisfaction with Life Scale (SWLS)
PROMIS Physical Function
PROMIS Pain Interference
Example of AUDIT questions 1,2 and 3
Example of AUDIT question summary
Daily Safety Survey
It’s essential to collect as much relevant data as possible on the patient experience and how well treatment is working during a clinical trial. One of the most effective and accurate tools to do this is through electronic patient-reported outcomes (ePRO).
There are really 4 major advantages to using ePRO:
Cost reduction – Using ePRO saves costs on devices, duplicated data, and data collection. With these savings, it alternatively reduces cost on the number of resources and employees needed to collect and analyze the data.
Once you’ve decided the feedback you want from your patients, you can decide on the best format to capture the information. There are four basic types of ePRO collection methods. Each collection type has its own merits and disadvantages. When you are planning to incorporate ePROs, you need to consider the collection method and if it will work for your organization. You may find that using more than one collection method advantageous, depending on the patient population and intended use.
The trend that computers, tablets, and phones can all support browsers has made it easier to reach users in a variety of ways improving the online data collection experience.
All formats available offer patients the flexibility to use devices provided by the trial or an app installed on their device. The familiarity with a device the patient is already using and creating a collection method that is easy-to-use increases patient satisfaction and saves you time and money to collect, analyze, and disseminate the data results. The best ePRO applications look like phone apps and are easy to use and navigate.
Smartphone-based ePRO solutions can either be user-driven, like a headache diary or activity log, or they can be system-generated where the user will receive a message that it is time to share some data. The best solutions are short assessments that take only a few minutes to complete.
Now that more people are using fitness trackers, it provides the opportunity to collect information without any intervention with the participant. These can provide insight into sleep and movement patterns, both of which can give insight into a patient’s wellbeing.
ePROs gather a wide range of measurements to cover a patient’s health status. These methods record the patient’s physical status and record the mental and social well-being of the patient. Research has shown that non-clinical factors identified when using ePROs play a vital role in a patient’s overall health. Identifying clinically significant issues increases the ability of health and research providers to address issues and proactively work to preserve patient health.
There is also evidence that the real-time data collection of ePROs plays a role in improving outcomes.
A recent clinical trial showed that the survival interval of cancer patients was increased by 5 months when using ePROs. This is partly due to staff’s ability to respond quickly to potential issues and avoid consequences due to those issues.
If your study population is able to use systems to manage their data, they will likely expect an easy-to-use solution to interact with your study. Some of your participants may prefer to use the computer, but many will prefer the convenience of a smartphone data collection process. Make sure that the platform that you are considering has the built-in toolset to allow you to build and deploy ePRO simply and will allow your users to interact in the way that works best for them. Your system should also have the ability to integrate to a third-party application if that is required by your study protocol.
COVID has forced health care providers and clinicians to find new and innovative ways of tracking patient data and providing health care. This change over to a digital landscape can save you time, money, and resources. But it also creates the unique challenge of finding the right system for your specific needs.
Learn how you can simplify your clinical research data collection and integrate that data directly with the QuesGen electronic data capture system. Explore ePRO today and let us know if we can answer any questions!